The following data is part of a premarket notification filed by Cardinal Health 207, Inc. with the FDA for Heliox Low Flow Sentry Blender.
| Device ID | K092484 |
| 510k Number | K092484 |
| Device Name: | HELIOX LOW FLOW SENTRY BLENDER |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | CARDINAL HEALTH 207, INC. 22745 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Monther Abushaban |
| Correspondent | Monther Abushaban CARDINAL HEALTH 207, INC. 22745 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-13 |
| Decision Date | 2010-04-02 |
| Summary: | summary |